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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, carbon-dioxide, gaseous-phase
510(k) Number K140113
Device Name O2 NASAL CANNULA WITH CO2 MONITORING
Applicant
FLEXICARE MEDICAL LTD.
CYNON VALLEY BUSINESS PARK
MOUTAIN ASH
MID GLAMORGAN,  GB CF45 4ER
Applicant Contact CHRIS WATKINS
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/15/2014
Decision Date 03/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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